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NeuMoDx Gets CE Mark for SARS-CoV-2 Test

NEW YORK – NeuMoDx announced Monday its multiplex RT-PCR SARS-CoV-2 test received CE marking.

The NeuMoDx SARS-CoV-2 Assay detects SARS-CoV-2 RNA from the Nsp2 gene and N gene in nasopharyngeal, oropharyngeal, or nasal swab specimens. The test runs on the NeuMoDx 288 and 96 Molecular Systems with results in 80 minutes from primary collection or daughter tubes, the company said. The systems can run up to 288 patient samples and can be used by laboratories to validate their own laboratory-developed tests, NeuMoDx added. 

Reagents and consumables for the test don't need refrigeration and are offered in a ready-to-use format, which enables more efficient automation, President and COO of NeuMoDx Sundu Brahmasandra said in a statement.

The test received Emergency Use Authorization from the US Food and Drug Administration in March. In 2018, Qiagen and NeuMoDx inked a partnership and merger agreement under which Qiagen distributes the NeuMoDx 288 and 96 systems in Europe and other markets outside the US.